Policies and Procedures

101. Biomedical (IRB-01) and Social-Behavioral (IRB-02) Boards

102. About the IRB
     102.1 Disclosure of Financial Relationship for Sponsored Projects

103. IRB Member Confidentiality
     103.1 IRB Confidentiality Acknowledgement

104. Federal-wide Assurance/IRB Registration
     104.1 IRB Statement of Compliance

105. IRB Review Process
     105.1 Definitions for Human Subjects Research
     105.2 Human Subject Regulation Decision Charts
     105.3 Checklist for Member Review
     105.4 Biomedical Application for Initial IRB Review (IRB-01)

     105.5 Social-Behavioral Application for Initial IRB Review (IRB-02)

     105.6 Application for Response to IRB Requests
     105.7 Creighton University Human Research Protection Program Letter of Agreement
     105.8 Guidance: Criteria for Consideration in Risk Assessment

106. Duties of IRB Members
     106.1 IRB Member Evaluation

107. Evaluating Sound Study Design

108. Scientific/Methodological Review of Investigator-Initiated Research
     108.1 Reporting Form for Scientific/Methodological Review
     108.2 Guidance on Conducting Scientific/Methodological Reviews
     108.3 Guidance on Writing a Research Protocol

109. Expedited Categories

110. Medical Devices
     110.1 IRB Administrative Checklist for Research Involving Devices
     110.2 Examples of Non-Significant Risk Devices and Significant Risk Devices

111. Sponsor-Investigator Research Requirements (When a CU Investigator Holds the IND)
     111.1 IRB Administrative Checklist for Research Involving Drugs

112. Guidelines for Genetic Research

113. Recruiting Research Subjects
      113.1 Application for Web Posting of Recruitment Advertisement

114. Exempt (from the Codes of Federal Regulations) Research
     114.1A Application for Determination of Exempt Status: Educational Research
     114.1B Application for Determination of Exempt Status: Observation, Survey, Interview
     114.1C Application for Determination of Exempt Status and HIPAA Authorization Waiver for Medical Record Review
     114.1D Application for Determination of Exempt Status: Use of Biological Specimens in Research
     114.2 Exempt Application Checklist
     114.3 Guidelines for Quality Assurance Projects vs Research
     114.4 Information Letter Template (When Consent Documentation is Waived)
     114.5 IRB Guidelines for Student/Classroom Research Projects
     114.6 Guidelines for Identifying Studies That Are Not Human Subjects Research (Do Not Need IRB Review)

115. External Studies
115.1 Application for External Review

116. Vulnerable Research Populations
     116.1 IRB Member Checklist for Projects Involving Children
     116.2 IRB Member Checklist for Projects Involving Neonates
     116.3 IRB Member Checklist for Projects Involving Pregnant Women and Human Fetuses

117. Prisoners in Research
     117.1 IRB Member Checklist for Projects Involving Prisoners

118. Informed Consent (Including Permission/Assent)
     118.1 IRB Member Checklist for Informed Consent
     118.2 Consent/Permission Template
     118.3 Assent Template (age 7-11)
     118.4 Assent Template (age 12-18)
     118.5 Consent for Genetic Testing for Research Purposes
     118.6 Addendum Consent for Optional Protocol-Defined Genetic Research
     118.7 Addendum Consent for the Storage of Tissue or Blood for Undefined or Unspecified Future Genetic Testing
     118.8 Tips on Informed Consent-OHRP
     118.9 Glossary of Lay Terms for Use in Preparing Consent Forms
     118.10 Checklist for Waiver/Alteration of Consent or Authorization
     118.11 Bill of Rights for Research Participants

119. HIPAA for Researchers
     119.1A HIPAA Authorization Template Without Instructions
     119.1B HIPAA Authorization Template With Instructions
     119.2 Elements of a Valid HIPAA Authorization
     119.3 De-identified Health Information Under HIPAA
     119.4 Revocation of Authorization to Use and Disclose Health Information for Research Purposes
     119.5 Creighton University Notice of Privacy Practices
     119.6 DOCu Track for PHI
     119.7 Application for Waiver of HIPAA Privacy Authorization
     119.8 HIPAA Authorization Flow Chart

120. Unanticipated Problems Involving Risks to Participants or Others
     120.1 Unexpected Event Algorithm
     120.2 Replaced by 134.1, Reporting Form for Reportable New Information
     120.3 Examples of Violations and Deviations to an Approved Protocol

121. Continuing Review/Project Termination
     121.1 Continuing Review or Project Termination Application IRB-01
     121.2 Continuing Review or Project Termination Application IRB-02
     121.3 Continuing Review or Project Termination Application for Projects Determined to be Exempt

122. Modification of Approved Research
     122.1 Samples of Modifications and Type of Review Required
     122.2 Request for Modification of Approved Research
     122.3 Application for Request for Review of Supplemental Documents

123. Human Subjects Research Education Program
     123.1 Mandatory Educational Requirements for IRB Members

124. Review of Human Subject Research Activities by Other Creighton University Committees

125. Registering Clinical Trials (clinicaltrials.gov)

126. Additional DOD Regulations

127. Engaged in Research

128. Emergency Use of Unapproved Drugs/Devices/Biologics

129. Expanded Access to Investigational New Drugs

130. International Research

131. Noncompliant Conduct

132. Data and Safety Monitoring Plans

133. Community-Based Research

134. Reportable New Information
      134.1 Reporting Form for Reportable New Information

135. Suspensions and Terminations

Confidential Research Hotline (402-280-3200)

Research Personnel are expected to report any known or suspected noncompliant conduct related to research or sponsored program activities conducted and/or approved through Creighton University. The confidential Research Compliance Hotline (402-280-3200) is available for any individual who wishes to remain anonymous and/or has found other available reporting mechanisms to be ineffective. Research Personnel may also address their research compliance-related questions or concerns to Director of Research & Compliance at 402-280-2511.

Creighton University